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The MAGNETOM Verio is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and / or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM Verio may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR-safe biopsy needles.

The MAGNETOM Verio comes with I-class and T-class releases based on syngo MR B15B. It is a 3 Tesla MR scanner based on a superconducting magnet. It consists of the same types of hardware (with a modified magnet, gradient coil and RF body coil) that are currently available with the MAGNETOM Trio a Tim system including Matrix Coils and Total Imaging Matrix (Tim) technology.

The provided text describes the 510(k) summary for the Siemens MAGNETOM Verio, a magnetic resonance diagnostic device. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria for performance against a clinical ground truth.

Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided document. The study described focuses on technical performance metrics (e.g., Signal-to-Noise Ratio, Geometric Distortion) to show equivalence to a predicate device, not on diagnostic accuracy based on a clinical ground truth.

Acceptance Criteria and Device Performance

The provided 510(k) summary does not present specific acceptance criteria in terms of clinical performance (e.g., sensitivity, specificity, accuracy) for a diagnostic task, nor does it report the device's performance against such criteria. Instead, it demonstrates substantial equivalence by comparing technical performance parameters to a predicate device.

The "acceptance criteria" can be inferred as showing comparable or better technical performance compared to the predicate device for various physical parameters.

Study Details

The provided document describes a technical study demonstrating substantial equivalence rather than a clinical study evaluating diagnostic performance.

1. Sample size used for the test set and the data provenance: Not applicable in the context of diagnostic accuracy. The performance measurements were done on the MAGNETOM Verio and the predicate MAGNETOM Trio a Tim System through technical evaluations. The specific sample sizes (e.g., number of scans, phantoms) used for each technical measurement are not detailed, nor is the "provenance" of such technical data mentioned beyond it being generated by the manufacturer.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here refers to established physical standards (IEC, ISO, NEMA) for safety and predefined measurements for performance. There were no human experts establishing a clinical ground truth for diagnostic purposes in this submission.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical adjudication process was described or required for these technical performance metrics.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This submission is for an MRI scanner, not an AI-powered diagnostic algorithm. No MRMC study was mentioned.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but a medical device (MRI scanner). The "performance" assessment was for the device's physical and imaging capabilities.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission was based on established engineering standards (IEC, ISO, NEMA) for safety parameters and direct physical measurements for performance parameters (e.g., SNR, geometric distortion) on the device and its predicate.

7. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set. The device's design and manufacturing rely on established engineering principles and iterative development, not data-driven training in the AI sense.

8. How the ground truth for the training set was established: Not applicable. There was no "training set" or corresponding ground truth in the context of an AI/ML device.

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The MAGNETOM Systems with the syngo MR2006A are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

The "MAGNETOM Espree", the "MAGNETOM Avanto", the "MAGNETOM Symphony a Tim System", the "MAGNETOM Trio a Tim System" may also be used for imaging during interventional procedures performed with MR compatible instruments in room display and MR safe biopsy needles.

The MAGNETOM Systems with the syngo MR2006A are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities.

This document describes a 510(k) premarket notification for a software and hardware upgrade (syngo MR2006A) to existing Siemens MAGNETOM MRI systems. The primary claim is substantial equivalence to previously cleared devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, there are no specific quantitative acceptance criteria or reported device performance metrics listed in a table format. The submission focuses on demonstrating substantial equivalence by stating that the upgrade has "no significant effect on the MR safety and performance parameters" and that "the values are not significantly changed and, in the case of safety parameters remain below the level of concern."

The key "performance" claim is that the device will "conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices." However, no specific performance values against these standards are provided in the excerpt.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not mention any specific test set sample size or data provenance (e.g., country of origin, retrospective or prospective) for proving the device meets acceptance criteria. The focus is on the upgrade's impact on existing, cleared MRI systems.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

No information is provided regarding the number or qualifications of experts used to establish ground truth for a test set. This type of information would typically be present in studies evaluating diagnostic accuracy or clinical performance, which are not detailed in this submission.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned. Since there's no described test set involving human interpretation for ground truth establishment, adjudication methods are not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC comparative effectiveness study is mentioned. The submission does not discuss human readers or improvements with AI assistance. The device is an MRI system software/hardware upgrade, not an AI-assisted diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

No standalone study demonstrating "algorithm only" performance is explicitly mentioned. The document states that the new software has "no significant effect on the MR safety and performance parameters" of the existing MRI systems. This implies that the upgrade itself was tested for its impact on the system's performance, but not as a standalone algorithm with a specific diagnostic output.

7. The Type of Ground Truth Used:

Given the nature of the submission (upgrade to an existing MRI system for substantial equivalence), the "ground truth" used for evaluation would primarily be derived from technical performance specifications and safety parameters as defined by NEMA and IEC standards for MRI devices. It's not a clinical ground truth like pathology or outcome data in the context of diagnostic accuracy. The key point is that the upgraded system continues to meet the established performance and safety characteristics of the predicate devices.

8. The Sample Size for the Training Set:

No training set sample size is mentioned. This type of information is typically relevant for machine learning or AI models, which are not the focus of this submission.

9. How the Ground Truth for the Training Set Was Established:

As no training set is mentioned, there is no information on how its ground truth was established.

Summary of Key Findings from the provided text:

• Acceptance Criteria/Performance: The primary acceptance criterion appears to be maintaining the safety and performance parameters of the predicate devices, conforming to NEMA and IEC standards, with "no significant effect" from the upgrade. Specific quantitative criteria and reported values are not provided in this excerpt.
• Study Design: The document describes an assessment for "substantial equivalence" of a software/hardware upgrade to existing MRI systems. It implies internal testing against established industry standards for performance and safety, rather than a clinical trial with a distinct test set or human readers.
• Lack of Detail: The provided text is a 510(k) summary focused on establishing substantial equivalence based on the minor nature of the changes. It does not contain the detailed study protocols, acceptance criteria tables, or performance metrics typically found in submissions for novel diagnostic devices or AI algorithms.

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